Menat Urmila, Desai Chetna K, Panchal Jigar R, Shah Asha N
Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India.
Department of Medicine, GCS Medical College, Ahmedabad, Gujarat, India.
Perspect Clin Res. 2021 Jan-Mar;12(1):33-39. doi: 10.4103/picr.PICR_30_19. Epub 2019 Dec 20.
The objective of this study is to evaluate the trigger tool method (TTM) in detection, monitoring, and reporting of adverse drug reactions (ADRs) at Civil Hospital Ahmedabad, India.
A prospective, single-center, observational cum intervention study was conducted in two phases in the Department of Medicine over 15 months. In phase I, preliminary trigger tool list (PTTL) comprising 55 triggers was evaluated by pharmacologist in terms of detection of ADR in 400 patients and then, modified trigger tool list (MTTL) was prepared. In Phase II, the TTM using MTTL was compared with the spontaneous method of ADR monitoring after educational interventions in resident doctors of the two units of medicine department.
Of the 55 triggers in PTTL, 34 triggers were observed in 327 patients, of which 19 triggers lead to the detection of 66 ADRs. The rate of ADEs was 16.5%/100 patients. Positive predictive value (PPV) of each trigger ranged from 0% to 100%. PPV for drug trigger, laboratory trigger, and PT was 14.4%, 4.5%, and 23.3%, respectively. Overall, PPV of PTTL was 19.27%. Sensitivity and specificity were 100% and 21.66%, respectively. MTTL consists of these 19 triggers. In Phase II, resident doctors reported 16 ADRs, using spontaneous method and 23 ADRs using MTTL. The rate of ADEs per 100 patients was 1.63 and 2.13, respectively, with these methods. A total of 105 ADRs were reported during both phases.
TTM is an effective method of ADR reporting if it is utilized by a trained person. This method could be used as add-on method to spontaneous method to improve ADR reporting.
本研究的目的是评估触发工具法（TTM）在印度艾哈迈达巴德市民医院检测、监测和报告药物不良反应（ADR）中的应用。
在医学科进行了一项为期15个月的前瞻性、单中心、观察性兼干预性研究，分两个阶段进行。在第一阶段，由药理学家对包含55个触发因素的初步触发工具列表（PTTL）在400例患者中检测ADR的情况进行评估，然后编制修改后的触发工具列表（MTTL）。在第二阶段，在医学科两个单元的住院医生接受教育干预后，将使用MTTL的TTM与ADR监测的自发方法进行比较。
在PTTL的55个触发因素中，327例患者出现了34个触发因素，其中19个触发因素导致检测到66例ADR。ADEs发生率为16.5%/100例患者。每个触发因素的阳性预测值（PPV）范围为0%至100%。药物触发因素、实验室触发因素和PT的PPV分别为14.4%、4.5%和23.3%。总体而言，PTTL的PPV为19.27%。敏感性和特异性分别为100%和21.66%。MTTL由这19个触发因素组成。在第二阶段，住院医生使用自发方法报告了16例ADR，使用MTTL报告了23例ADR。使用这些方法时，每100例患者的ADEs发生率分别为1.63和2.13。两个阶段共报告了105例ADR。
如果由经过培训的人员使用，TTM是一种有效的ADR报告方法。该方法可作为自发方法的补充方法，以改善ADR报告。
